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Completed Phase 1Phase 2 Interventional

Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds

ClinicalTrials.gov ID: NCT00161759

Public ClinicalTrials.gov record NCT00161759. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 4:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Study to Assess the Safety and Efficacy of Fibrin Sealant (FS 4IU) for Wound Healing in Subjects With Burn Wounds Requiring Skin Grafting Procedures

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.

Study identification

NCT ID
NCT00161759
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Baxter Healthcare Corporation
Industry
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 65 Years
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2002 (Type not available)
Primary completion
Not listed
Completion
Jan 2004 (Type not available)
Last update posted
Oct 20, 2006

2002 – 2004

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
University of South Alabama Medical Center Mobile Alabama 36617 —
Maricopa Medical Center Phoenix Arizona 85008 —
UCI Medical Center Orange California 92868-3298 —
University of California Davis Medical Center; Shriners Hospitals for Children Sacramento California 95817 —
UCSD Medical Center San Diego California 92103-8896 —
Bridgeport Hospital Bridgeport Connecticut 06610 —
Joseph M. Still Burn Center at Doctors Hospital Augusta Georgia 30909 —
Loyola University Medical Center Maywood Illinois 60153 —
Shriners Hospitals for Children Cincinnati Ohio 45229 —
Wright State University, Miami Valley Hospital Dayton Ohio 45409-2722 —
Shriners Hospitals for Children, Galveston Galveston Texas 77550-2725 —
University of Washington Burn Center Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00161759, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 20, 2006 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00161759 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →